ASMF/DMF, eCTD will become mandatory on short notice:
· From January 2017 EDQM will require
eCTD submissions for new applications for CEPs.
Currently eCTD represents less than 20% of the formats received by EDQM.
The preferred way of submission to EDQM is through CESP.
· From June 2017, FDA is implementing eCTD
as mandatory format for DMFs
note that the EU Harmonization group is working on the release of the ASMF eCTD
best practice guide, which will be released soon.
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